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Applied For Licence In US, Says Bharat Biotech’s American Partner

Applied For Licence In US, Says Bharat Biotech's American Partner

“Covaxin is the only product to have any data on emerging variants,” Bharat Biotech stated. (File)

New Delhi:

India’s first indigenous COVID-19 vaccine producer Bharat Biotech on Saturday stated that will probably be finishing up medical trials within the US to help the advertising utility for Covaxin within the nation.

On Thursday, Ocugen, the US accomplice for Bharat Biotech’s COVID-19 vaccine stated, it has submitted for a Biologics License Application (BLA) for the jab, as an alternative of looking for Emergency Use Authorisation (EUA) as initially deliberate.

On Phase 3 medical trial knowledge, Bharat Biotech stated it has shared complete knowledge of all analysis research of Covaxin to the regulators in India.

As per the corporate launch research of Covaxin, “The complete data for Phase I and II, and partial data for Phase III trials of COVAXIN(r) have been thoroughly scrutinized by the regulators in India. In a timely approach to peer review, the company has already published as many as nine research studies on the safety and efficacy of COVAXIN(r) in five globally reputed peer-reviewed journals in a span of just twelve months.”

“COVAXIN(r), a whole-virion inactivated coronavirus vaccine, has many firsts to its credit in data transparency. It is the first and only product to have published any data from human clinical trials in India. It is the only product to have any data on emerging variants. It is also the first and only COVID-19 vaccine to have efficacy data in Indian populations,” Bharat Biotech stated.

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